Comparative Clinical Evaluation of Unani Formulation in redesigned gel form with its classical Bukhoor form in the Management of Knee Osteoarthritis.

The clinical study entitled “Comparative clinical evaluation of Unani formulation in redesigned gel form with classical Bukhoor form in the management of knee osteoarthritis†is carried out in OPD/IPD of Majeedia Unani hospital, Jamia Hamdard, New Delhi. The study is approved by the IEC, Jamia Hamdard. It is interventional, open, randomized, comparative control study of duration 1 ½ years and of 4 weeks protocol therapy with a total sample size of 40 patients and 20 in each group.The objective of this study is to redesign and develop gel form of the Unani formulation and to study its efficacy and safety in the management of knee osteoarthritis. The effect of this gel is to be compared with its bukhoor form (medicated steam) in pain management and also to assess the overall improvement in the quality of life inpatients of knee osteoarthritis. The total 40 patients will be randomized into two groups. Gel form of the Unani formulation is to be given to the patients of group A for local application twice a day (4 grams of gel for 1 knee joint in one time for 4 weeks) and bukhoor will be given to the patients of group B for four weeks (medicated steam will be performed once daily for first 5 days in 1st week, 3 times alternatively in 2nd week and 2 times in 3rd and 4th week in the hospital. All the male and female, Knee OA patients, aged 40 to 65 years, with pain, morning stiffness **≤**30 minutes duration, crepitus on active movement and presence of osteophytes on knee radiograph and with pain intensity score of 3 cm or more on a 10 cm on VAS and willing to accept the intervention and complying with the protocol will be included.  Patients taking NSAID’s and corticosteroids, a wash out period of 1week and 4 weeks respectively, is required before enrolling such patients. The patients will be assessed at day 0 and every week for 1 month and the data will be collected and recorded in CRF. The assessment parameters for screening and safety are CBC with ESR, LFT & KFT,  X- ray Knee AP and lateral view.  The parameters for the assessment of efficacy   are VAS, KOOS, ROM, knee circumference, skin temperature over knee, tenderness on 4-Point Likert Scale. Response of the patient and the investigator to the therapy on a 5-point Likert Scale (0-4) by PGA and IGA respectively. The quality-of-life will be assessed by SF-12. Adverse effects if any will be immediately recorded and action will be taken in consultation with the physician. The decision for inclusion or exclusion will be taken on interest of the patient. The same will be reported to Institutional Ethics Committee. All the data will be compiled and the results will be analyzed after appropriate statistical application.